Medical Devices & Diagnostics

Transcription

1 SOLUTIONS FOR Medical Devices & Diagnostics PRECISION CONVERTING & CONTRACT MANUFACTURING

2 The stakes have never been higher. The marketplace is rapidly evolving. Companies are facing unprecedented constraints on time, funding, and resources. At the same time, they are tasked with balancing their mission to improve peoples lives with the complexity of bringing innovative diagnostics to market. To succeed, companies need to rethink their strategies for overcoming technological barriers to deliver value to both their customers and their investors. The first step is choosing the right manufacturing partner.

3 The right Contract Manufacturer (CMO) makes all the difference. By the time a product has been designed about 10% of the total product budget has been spent. At that time, the design has determined 80% of the cost of the product. Successful companies know that aligning with the right CMO can yield monumental benefits. Partnering early in the product development cycle contributes fresh thinking and helps identify potential material and manufacturing issues before they become problems. It removes risk and burden inherent with device development, allowing you to focus on meeting your strategic goals. It integrates important facets of the commercialization process such as supply chain management and product life cycle planning with production. It accesses an existing manufacturing footprint that utilizes innovative automation to deliver millions of devices each year, addressing speed-to-market and overall cost containment concerns. Ultimately, by moving the commercialization, regulatory, and day-to-day manufacturing details to a trusted partner, early alignment with the right CMO allows you to concentrate on your core competencies precisely where you add the most value.

4 A reputation for innovation, accountability, and integrity. Web Industries specializes in high-tech commercialization solutions for medical devices and diagnostics. Utilizing the latest automated technologies combined with in-house biochemistry preparation, rigorous quality systems, and structured process transfer procedures, we provide contract manufacturing services designed for high-volume production that are easily scalable to millions of devices. Ingenuity is who we are. Overcoming challenges and getting your product to market is what we do. Trusted to offer a valued outside perspective, we re as innovative as we are meticulous. We know that our success is inexorably linked to your success. That s why we protect your brand as if it was our own. Over the past two decades, we have been trusted to manufacture more than 100 billion medical and life science diagnostic tests and devices.

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6 Reducing risks. Improving outcomes. At Web Industries, we realize the importance of our role in your success, which is why we bring a simple, consultative approach to creative problem solving. We listen to your needs. We develop close, collaborative relationships with you and your team. We share what we ve learned from our years in the business. We innovate. We streamline your development process. And we make sure to make good on our promises. When you work with Web Industries, know this: You re working with a partner, not a supplier.

7 There is a difference between a CMO that listens and one that actually hears you. MEDICAL DEVICE COMPANY SEES EIGHT-FOLD PRODUCTION INCREASE FROM CUSTOMIZED CONTRACT MANUFACTURING WITH WEB. Recurring workflow bottlenecks and quality issues with their existing supplier were requiring the marketers of a blood irradiation indicator to heavily manage production schedules to ensure order fulfillment. They turned to Web Industries for a contract manufacturing solution with greater capacity, improved quality assurance, and increased efficiencies. Manufacturing was reconfigured to utilize precision modular converting lines combining multiple web-based raw materials into discrete subassemblies and then into finished devices. In-line vision inspection systems monitoring all critical-to-safety features addressed both quality assurance and real-time data monitoring concerns, and new component materials optimized for the new production methods were sourced and qualified, increasing overall yields. Once the new process was proven to the customer, Web was authorized to ship finished devices directly to the end users, eliminating client oversight burdens. PRIMARY BENEFITS Eight-fold increase in production rates Significant improvement in quality and reliability Improved yields leading to reduced unit costs Reduction in burdensome oversight allowed partner to focus on market expansion and new product innovation

8 What Web Industries can do for you. Web Industries is deeply passionate about improving people s lives. We combine our expertise in biochemistry, flexible material converting, and medical device manufacturing to deliver high commercial volumes, consistency, and overall quality. AREAS OF FOCUS Clinical Animal Health Food, Crops & Water Biodefense Point of Care Advanced Wound Care Hospital Supplies

9 LATERAL FLOW DIAGNOSTICS CENTER OF EXCELLENCE Our one-stop manufacturing solution offers a reliable path from small-scale test development to high-volume commercialization of new LFI devices. Purpose-built for automated reel-to-reel medical device production, it features an in-house biochemistry lab, reagent deposition, LFI strip manufacturing, device assembly, and packaging. PRODUCT DEVELOPMENT AND EVALUATION Working to get our partners products off the drawing board and into the marketplace, our product transfer process applies designing for manufacturability insights to uncover hidden material or design issues early in product development. STATE-OF-THE-ART AUTOMATED PROCESSES Combining automated manufacturing with in-house chemistry prep and rigorous quality systems delivers a medical device manufacturing platform designed for highvolume production of high-value tests while ensuring the quality and consistency that the market demands.

10 PRECISION MEDICAL CONVERTING SOLUTIONS We understand the high quality and regulatory requirements of the medical market, and our customized material handling and converting solutions, combined with our product life cycle planning and supply chain management services, streamlines manufacturing administration overhead. MULTI-LAYER INSULATION BLANKETS Our multi-layer insulation (MLI) blankets provide custom-tailored cryogenic insulation solutions for medical equipment. These blankets offer exceptional performance, ease of installation, simplified procurement, and unique affordability. QUALITY ASSURANCE Our automated platforms produce LFI devices that meet or exceed market expectations for low CV, high sensitivity, and high specificity, empowering LFI companies to develop the higher-value quantitative tests that the market demands.

11 STRATEGIC FOCUS By providing automated endto-end high-volume medical manufacturing, device assembly, and packaging, we handle the daily production details, freeing our partners to focus on developing new products to meet strategic goals. CONTINUOUS IMPROVEMENT After successful commercialization, we constantly examine suppliers, processes, and systems to drive out waste and ensure high efficiency. NON-COMPETING PARTNER Web Industries does not manufacture any self-branded devices, making our company the only true non-competing CMO to offer automated end-to-end high-volume medical device manufacturing, assembly, and packaging services in the market.

12 Put us to work for you. Looking for value? Aiming to reduce your risks? Web Industries is your CMO partner. Contact us to find out how our industry-leading precision converting and manufacturing can help you meet your targets, gain market share, and maximize your profitability. t sales@webindustries.com Web Industries is 100% employee-owned Web Industries, Inc. All rights reserved.